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European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
News article25 November 2011European Medicines Agency

ENCePP interpretation of the definition of non-interventional trials

On 22 November 2011 the ENCePP Steering Group adopted the ENCePP position paper on the interpretation of the definition of non-interventional trials under the current legislative framework (“Clinical Trials Directive” 2001/20/EC). The aim of this position paper is to promote a common interpretation and understanding of the definition of ‘non-interventional trial’ in the context of the current legislative framework and based on widely accepted methodological definitions and clinical practice. This, in turn, is to further facilitate post-authorisation medicines research, thereby protecting and promoting public health.

For more information see:

- ENCePP interpretation of the defintion of non-interventional trials

Details

Publication date
25 November 2011
Author
European Medicines Agency